Senior Manager Inspection Audit Readiness
Senior Manager Inspection Audit Readiness
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Job Description
Job Description Summary
Responsible for management and coordination of global GVP/GCP inspection & audit participation conduct of global PS&PV selfassessments and contribute to review of draft new and changed pharmacovigilance/device vigilance regulatory requirementsJob Description
Major accountabilities:
- Responsible to provide coordination of central pharmacovigilance subject matter expert input and preparation for GVP or GCP inspections EMA or national
- Establishment and maintenance of communication channels (SharePoint Teams) etc for the inspection preparation
- Providing guidance to SME on expectations and content delivery
- Review of requests by inspectors and ensuring timely provision
- Maintenance of SME list
- Inspection observation impact assessment for vigilance partners
- Routine upcoming inspection notification to pharmacovigilance community in Novartis
- Responsible for the coordination and management of audits and audit readiness in the central sites including response development
- Management of 1QEM for assigned audits
- Audit observation impact assessment for vigilance partners
- Collation of insights across audits to provide lessons learned and support selfassessment target identification
- Support mentoring for effective audit and inspection readiness in the global ESPs supporting pharmacovigilance activities.
- Support global PS&PV selfassessment facilitation and management Deputise for Global Head I&AR in the review of draft new or revised pharmacovigilance/ device vigilance regulatory initiatives requirements and guidelines. When required conduct an impact assessment for changes in requirements impacting audits and inspections.
Minimum Requirements:
- Life science Degree
- Good knowledge /Fluency in English . Knowledge of other language desirable.
- Experience mainly in a Clinical Safety Department & closely related areas eg Clinical Development.
- Must have knowledge of global regulations for Pharmacovigilance/ Device vigilance
- Global vision of Pharmacovigilance/device vigilance process interrelationships
Why Novartis:Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together : to Diversity & Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
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Clinical Trial Databases Employee Training Pharmacovigilance Reporting Safety Science Team Management Waterfall ModelRequired Experience:
Senior Manager
Employment Type
Full-Time
